Donor Umbilical Cord Blood Transplant By Injection Into the Bone Marrow in Treating Patients With Hematologic Cancer

December 3, 2017 updated by: Masonic Cancer Center, University of Minnesota

A Phase I/II Study of Double Unit Umbilical Cord Blood (UCB) Transplantation Utilizing Graft Administration Via Intra-Bone Marrow Injection (Companion Protocol to MT2000-25)

Rationale: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from the donor's umbilical cord blood are injected into the patient's bone marrow they may help make stem cells, red blood cells, white blood cells, and platelets.

Purpose: This phase I/II trial is studying the side effects of donor umbilical cord blood transplant when given directly into the bone marrow and to see how well it works in treating patients with hematologic cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Objectives:

Primary

  • Determine the safety, in terms of infusional toxicity, of myeloablative unrelated donor double-unit umbilical cord blood (UCB) transplantation via intra-bone marrow injection (IBMI) in patients with advanced or high-risk hematologic malignancy.
  • Determine whether treatment with this regimen improves the time to neutrophil engraftment (compared to historical controls) in these patients.

Secondary

  • Determine the incidence of sustained donor engraftment in patients treated with this regimen.
  • Determine the relative contribution of each UCB unit to initial and sustained donor engraftment in these patients.
  • Determine the incidence of grade II-IV and grade III-IV acute graft-vs-host disease (GVHD) and chronic GVHD in patients treated with this regimen.
  • Determine the incidence of day 100 and 180 transplant-related mortality in patients treated with this regimen.
  • Determine the probability of survival at 100 days and 1 year post-transplantation in these patients.

Outline: This is a nonrandomized study.

Patients receive a myeloablative conditioning regimen. Patients also receive immunosuppression, growth factor, and supportive care as in protocol MT2005-10 (NCT00309842).

Patients receive 2 units of donor umbilical cord blood (UCB) by intra-bone marrow injection (IBMI) over 10 minutes each on day 0. If the IBMI procedure is not possible, then the UCB units are given intravenously (IV.)

After completion of study therapy, patients are followed periodically for 5 years.

Projected Accrual: A total of 36 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute myeloid leukemia (AML): high risk CR1
  • Acute lymphocytic leukemia (ALL): high risk CR1 [t(9;22), t (1:19), t(4;11) or other MLL rearrangements] or > 1 cycle to obtain CR; CR2+. All patients must be in CR as defined by hematological recovery, AND <5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%.
  • Chronic myelogenous leukemia (CML) excluding refractory blast crisis. To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to imatinib mesylate.
  • Myelodysplasia (MDS) IPSS Int-2 or High risk (i.e. RAEB, RAEBt) or refractory anemia with severe pancytopenia or high risk cytogenetics.
  • Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma or follicular lymphoma that have progressed after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm).
  • Lymphoplasmacytic lymphoma, mantle-cell lymphoma, prolymphocytic leukemia are eligible after initial therapy in CR1+ or PR1+.
  • Large cell NHL > CR2/> PR2. Patients in CR2/PR2 with initial short remission (<6 months) are eligible.
  • Lymphoblastic lymphoma.
  • Multiple myeloma beyond PR2.
  • Karnofsky performance status (PS) 90-100% (adults)
  • Lansky PS 50-100% (children)
  • Acceptable organ function

Exclusion Criteria:

  • Active infection at time of transplantation
  • History of HIV infection
  • Pregnant or breast feeding.
  • Chemotherapy refractory large cell and high grade NHL (ie progressive disease after > 2 salvage regimens)
  • Extensive prior therapy including > 12 months alkylator therapy or > 6 months alkylator therapy with extensive radiation.
  • Diffuse myelofibrosis of BM (bone marrow) (any severity) regardless of primary diagnosis (focal fibrosis acceptable provided it involves < 20% of BM volume).
  • History of pelvic irradiation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transplant Patients
Patients receiving umbilical cord blood transplantation.
Procedure: umbilical cord blood transplantation
The graft will be given by slow injection into each posterior iliac crest.
Other Names:
  • UCBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Number of Days to Neutrophil Engraftment
Time Frame: Daily through Day 60 post transplant
Number of days to neutrophil recovery observed in recipients of two umbilical cord blood units (UCB)administered i.v. Neutrophil recovery is defined as first of 3 consecutive days with ANC (absolute neutrophil count) greater than or equal to 500/ul.
Daily through Day 60 post transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Achieving Neutrophil Recovery
Time Frame: 6 months
Number of patients with sustained neutrophil recovery with chimerism (evidence of engraftment of both cord blood transplants) at 6 months.
6 months
Number of Patients With Evidence of Engraftment.
Time Frame: 1 year
Number of patients who received both cord blood units and achieved sustained donor engraftment
1 year
Number of Patients With Acute Graft-versus-host Disease (GVHD)
Time Frame: 100 days post transplant
Number of patients who exhibited grade II-IV acute GVHD at 100 days post umbilical cord blood transplant.
100 days post transplant
Number of Patients With Transplant-related Mortality (TRM)
Time Frame: Day 100 and Day 180
Number of patients who were deceased at days 100 and 180 from any cause other than relapse.
Day 100 and Day 180
Number of Patients Surviving at Day 100 and 1 Year.
Time Frame: Day 100 and 1 year
Overall survival of patients-Number of patients who were alive at Day 100 and 1 year post transplant.
Day 100 and 1 year
Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD)
Time Frame: 100 days post transplant
Number of umbilical cord blood transplant patients developing severe GVHD at 100 days post transplant.
100 days post transplant
Number of Patients With Chronic Graft-versus-host Disease (GVHD).
Time Frame: 1 year post transplant
Number of umbilical cord blood transplant patients with limited and extensive chronic GVHD.
1 year post transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masonic Cancer Center, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

February 23, 2006

First Submitted That Met QC Criteria

February 23, 2006

First Posted (Estimate)

February 24, 2006

Study Record Updates

Last Update Posted (Actual)

December 28, 2017

Last Update Submitted That Met QC Criteria

December 3, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004LS072
  • UMN-MT2004-26 (Other Identifier: Blood and Bone Marrow Transplant Program)
  • UMN-0412M65789 (Other Identifier: IRB at University of Minnesota)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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